RELEXXII
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
No qualifying TRUE_DS/DS-equivalent or historical full-scope regulatory anchor established. Apply APPROVAL_YEAR_FALLBACK and retain all formulation/use FTO facts.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10265308 | 2037-02-03 | DP/U U-4032 | N | N | DP | — | — | — |
| 10265308 | 2037-02-03 | DP/U U-4032 | N | N | DP MPH extended-release dosage form with specified alcohol resistance and release profiles. DP. | — | — | — |
| 10695336 | 2037-02-03 | U U-4032 | N | N | U | — | — | — |
| 10695336 | 2037-02-03 | U U-4032 | N | N | U Claim 1 specifies about 54 mg, but independent claim 17 covers 2.5-90 mg and dependent claim 21 expressly includes 45 mg and 63 mg. Required immediate/extended-release, ethanol-resistance and dissolution-profile conditions prevent a DS-equivalent upgrade. U with formulation limitations; no unrestricted substance claim. | — | — | — |
| 9707217 | 2037-02-03 | DP — | N | N | DP | — | — | — |
| 9707217 | 2037-02-03 | DP — | N | N | DP Osmotic device and quantitatively specified release profiles are required. DP. | — | — | — |
| 9827234 | 2037-02-03 | U U-4032 | N | N | U | — | — | — |
| 9827234 | 2037-02-03 | U U-4032 | N | N | U Treatment claims require an osmotic device and specific ethanol/release profiles. Broad therapeutic wording alone does not prove unavoidable coverage for every bioequivalent 45/63 mg formulation. | — | — | — |
| 9855258 | 2037-02-03 | DP/U U-4032 | N | N | DP | — | — | — |
| 9855258 | 2037-02-03 | DP/U U-4032 | N | N | DP Osmotic device, semipermeable membrane, immediate-release coating and alcohol-resistant release conditions are required. DP. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| No exclusivity facts are recorded in this product snapshot. | ||||||||
2026-10-12 · NO_REGULATORY_EXCLUSIVITY_IDENTIFIED · Historical coverage: ANNUALS_2011_2026_REVIEWED
2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| 216117 / 006 | AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED | — | — | Osmotica Pharmaceutical US LLC | Y | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
Market Entry Information
API filings, authorized generics and linked regulatory milestones.
API Master Files & Certifications 0 records
Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.
| API | Holder / manufacturer | Holder country | Filing type | Number | Status | Filed date | Available for reference | Source | Last verified |
|---|---|---|---|---|---|---|---|---|---|
| No master-file or certification records are linked through public manufacturer portfolios. | |||||||||
Authorized Generics 1 records
Authorized generics are shown separately from independent ANDA approvals.
| Application / product | Applicant | Event / status | First marketed | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| 216117 / 006 | Osmotica Pharmaceutical US LLC | AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED | — | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Tentative ANDA Approvals 0 records
Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.
| Application / product | Applicant | Event / status | Tentative date | Follow-up final approval | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|---|
| No tentative-approval records are linked to this product. | |||||||
Paragraph IV Challenges 0 records
Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.
| Application / product | Applicant | Event / status | Certification event date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No structured Paragraph IV certification events are linked in the available approval evidence. | ||||||
Final ANDA Approvals 0 records
Approval dates do not establish commercial launch. Product mapping is shown for each linked record.
| Application / product | Applicant | Event / status | Final approval date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No final-approval records are linked to this product. | ||||||
Decision evidence (6)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2037-02-03 | FTO_TAIL | Osmotic device, semipermeable membrane, immediate-release coating and alcohol-resistant release conditions are required. DP. | Source |
| PATENT | 2037-02-03 | FTO_TAIL | Treatment claims require an osmotic device and specific ethanol/release profiles. Broad therapeutic wording alone does not prove unavoidable coverage for every bioequivalent 45/63 mg formulation. | Source |
| PATENT | 2037-02-03 | FTO_TAIL | Claim 1 specifies about 54 mg, but independent claim 17 covers 2.5-90 mg and dependent claim 21 expressly includes 45 mg and 63 mg. Required immediate/extended-release, ethanol-resistance and dissolution-profile conditions prevent a DS-equivalent upgrade. U with formulation limitations; no unrestricted substance claim. | Source |
| PATENT | 2037-02-03 | FTO_TAIL | MPH extended-release dosage form with specified alcohol resistance and release profiles. DP. | Source |
| PATENT | 2037-02-03 | FTO_TAIL | Osmotic device and quantitatively specified release profiles are required. DP. | Source |
| REGULATORY_STATUS | 2022-06-23 | DECISION_BASIS | No qualifying TRUE_DS/DS-equivalent or historical full-scope regulatory anchor established. Apply APPROVAL_YEAR_FALLBACK and retain all formulation/use FTO facts. | Source |
Litigation & Settlement History
Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.
No litigation or settlement record currently linked to this product.